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 Brochure
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| Feasibility Assessment |
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As part of the clinical manufacturing programme,
PX’Pharma will first assess the biopharmaceutical’s ability
to be manufactured under GMP environment.
Option A – No production
history for the protein of interest
In case where no protocol is to be
transferred by our customer
or detailed in the literature, PX’Pharma will perform a complete feasibility
study in order to assess the protein’s ability to proceed to GMP production.
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Bibliographic
study
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Selection
and evaluation of strains, plasmids and vectors compatible
with GMP process
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Expression, solubility
and capture tests |
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Development and optimization
of a production and purification scheme (small scale, research
grade) |
Option
B – Production protocol
available (from the client , from literature)
The feasibility study will include:
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Protocol
transfer, reproduction and validation
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Selection and evaluation
of strains, plasmids and vectors compatible with GMP process |
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Expression, solubility
and capture tests |
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If required, optimization
of the production and purification schemes (small scale,
research grade) |
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